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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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 Class 2 Device Recall Philipssee related information
Date Initiated by FirmJune 14, 2023
Date PostedOctober 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0020-2025
Recall Event ID 95324
510(K)NumberK130849 K131872 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductIntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Code Information UDI-DI: (01)00884838038769(21); (01)00884838038776(21); (01)00884838038783(21 Serial Numbers: DE7580BB1Y DE7580BB1Z DE7580BB20 DE7580BB21 DE7580BB22 DE7580BB23 DE7580BB24 DE7580BB25 DE7580BC47 DE7580BC48 DE7580BC4L DE7580BC4M DE7580BC4N DE7580BC4P DE7580BC4T DE7580BC4U DE7580BC5K DE7580BC5L DE7580BC5N DE7580BC5P DE7580BC5R DE7580BC5T DE7580BC5U DE7580BC5V DE7580BC68 DE7580BC69 DE7580BC6A DE7580BC6B DE7580BC6C DE7580BC6D DE7580BC6E DE7580BC6R DE7580BC6Z DE7580BC8R DE7580BCV4 DE7580BD4K DE7580BD4L DE7580BF3Z DE7580BFUL DE7580BFUM DE7580BFUN DE7580BFWY DE7580BJM2 DE7580BJM3 DE7580BJM4 DE7580BJM5 DE7580BJM6 DE7580BJM7 DE7580BJWV DE7580BJWW DE7580BJWY DE7580BJWZ DE7580BJY0 DE7580BJY1 DE7580BK55 DE7580BK56 DE7580BK75 DE7580BK76 DE7580BK77 DE7580BK78 DE7580BK79 DE7580BK7A DE7580BK7B DE7580BK7C DE7580BK7D DE7580BK7E DE7580BC3A DE7580BC3B DE7580BC3C DE7580BC3E DE7580BC3F DE7580BC3G DE7580BC3H DE7580BC3J DE7580BC3K DE7580BC3L DE7580BC3M DE7580BC3N DE7580BC3R DE7580BC3T DE7580BC3U DE7580BC3V DE7580BC3W DE7580BC3Y DE7580BC3Z DE7580BC40 DE7580BC41 DE7580BC42 DE7580BC43 DE7580BC75 DE7580BC79 DE7580BCY8 DE7580BCY9 DE7580BCYA DE7580BCYB DE7580BCYD DE7580BCYE DE7580BCYF DE7580BCYG DE7580BCYK DE7580BCYL DE7580BDE4 DE7580BDE5 DE7580BDE6 DE7580BDE7 DE7580BE0K DE7580BE0L DE7580BEWY DE7580BHZT DE7580BNKB DE7580BNKC DE7580BNKD DE7580BNKE DE7580BBBA DE7580BBUE DE7580BBUK DE7580BBUL DE7580BBUY DE7580BBUZ DE7580BBV0 DE7580BBV1 DE7580BBVC DE7580BBVD DE7580BBVE DE7580BBVF DE7580BBVU DE7580BBVV DE7580BBVY DE7580BBW9 DE7580BBWA DE7580BBWB DE7580BBWC DE7580BBWP DE7580BBWR DE7580BBYR DE7580BC2E DE7580BC2F DE7580BC2G DE7580BC2H DE7580BC2M DE7580BC2N DE7580BC2P DE7580BC2R DE7580BC2T DE7580BC2U DE7580BC2V DE7580BC2W DE7580BC2Y DE7580BC2Z DE7580BFVB DE7580BK89 DE7580BK8A DE7580BK8B
FEI Number 3016618143
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactPhilips Customer Services
800-722-9377
Manufacturer Reason
for Recall		Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
FDA Determined
Cause 2		Process control
ActionPHILIPS issued Urgent Field Safety Notice (2023-CC-HPM-019) on 6/14/23. Letter states reason for recall, health risk and action to take: " Please be aware that without Option C01 (Full Arrhythmia) the device will not provide the yellow alarms for enhanced arrhythmia detection. " Review the contents of this letter with your staff. " Pass this notice to all those who need to be aware within your organization or to any organization where the affected devices might have been transferred. 5. Actions taken by Philips to correct the problem Philips Representative will contact you to arrange reload of current device's software to enable missing software options (C0l, C13, C51, C54). If you need any further information, please contact your local Philips representative
Quantity in Commerce153 units OUS
DistributionForeign Only: Denmark France Germany Japan United Kingdom
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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